Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 07AUG2009 and 21AUG2009

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Time Frame

Day 0-7 after first vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the first vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

204

204

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
[units: Participants]

Pain

29

53

Tenderness

62

95

Swelling

23

26

No statistical analysis provided for Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination

2. Primary:

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Time Frame

Day 0-7 after second vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the second vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

201

201

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
[units: Participants]

Pain

33

45

Tenderness

60

91

Swelling

11

14

No statistical analysis provided for Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination

3. Primary:

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Time Frame

Day 0-7 after first vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the first vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

204

204

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
[units: Participants]

Swelling

29

31

Redness

26

29

No statistical analysis provided for Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination

4. Primary:

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Time Frame

Day 0-7 after second vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the second vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

201

201

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
[units: Participants]

Swelling

10

16

Redness

22

22

No statistical analysis provided for Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination

5. Primary:

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Time Frame

Day 0-7 after first vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the first vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

204

204

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
[units: Participants]

Feverishness

18

20

Malaise

39

51

Myalgia

27

28

Headache

37

34

Nausea

8

14

No statistical analysis provided for Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination

6. Primary:

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination

Measure Description

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Time Frame

Day 0-7 after second vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the second vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

201

201

Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
[units: Participants]

Feverishness

10

23

Malaise

28

36

Myalgia

22

23

Headache

35

33

Nausea

4

11

No statistical analysis provided for Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination

7. Primary:

Number of Participants Reporting Fever After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Fever After the First Vaccination

Measure Description

Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.

Time Frame

Day 0-7 after first vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the first vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

204

204

Number of Participants Reporting Fever After the First Vaccination
[units: Participants]

1

2

No statistical analysis provided for Number of Participants Reporting Fever After the First Vaccination

8. Primary:

Number of Participants Reporting Fever After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Measure Type

Primary

Measure Title

Number of Participants Reporting Fever After the Second Vaccination

Measure Description

Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.

Time Frame

Day 0-7 after second vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the second vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

201

201

Number of Participants Reporting Fever After the Second Vaccination
[units: Participants]

1

0

No statistical analysis provided for Number of Participants Reporting Fever After the Second Vaccination

9. Primary:

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 0 prior to and Day 8-10 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

97

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
[units: Participants]

Day 0

13

10

Day 8-10

78

81

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine

10. Primary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 0 prior to and Day 8-10 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

105

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
[units: Participants]

Day 0

16

18

Day 8-10

62

70

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine

11. Primary:

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine

Measure Description

Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 21 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

96

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
[units: Participants]

82

83

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine

12. Primary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine

Measure Description

Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 21 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

100

104

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
[units: Participants]

60

74

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine

13. Primary:

Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after last vaccination ]

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

Time Frame

Day 0 through Day 180 after last vaccination

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants receiving the first vaccination are included in the safety ITT cohort

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to and Day 8-10 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

97

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
[units: Participants]

71

75

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine

15. Primary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to and Day 8-10 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

105

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
[units: Participants]

50

58

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine

16. Primary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to and Day 21 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

102

96

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
[units: Participants]

77

78

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine

17. Primary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

Measure Type

Primary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine

Measure Description

Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to and Day 21 after first vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

100

104

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
[units: Participants]

54

62

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine

18. Secondary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to first vaccination and Day 8-10 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

99

93

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

77

80

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

19. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to first vaccination and Day 8-10 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

97

104

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

56

71

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

20. Secondary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to first vaccination and Day 21 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

99

94

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

81

78

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

21. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to first vaccination and Day 21 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

97

103

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

56

69

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

22. Secondary:

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 8-10 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 8-10 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

99

93

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

84

84

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

23. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 8-10 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 8-10 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

97

104

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

63

81

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.

24. Secondary:

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 21 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 21 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

99

94

Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

87

84

No statistical analysis provided for Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

25. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 21 after the second vaccination ]

Measure Type

Secondary

Measure Title

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

Measure Description

Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Time Frame

Day 21 after the second vaccination

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.

Reporting Groups

Description

H1N1 Vaccine 15 Mcg

Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

H1N1 Vaccine 30 Mcg

Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Measured Values

H1N1 Vaccine 15 Mcg

H1N1 Vaccine 30 Mcg

Number of Participants Analyzed
[units: participants]

97

103

Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
[units: Participants]

60

80

No statistical analysis provided for Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.